Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Field reports plus an in house study indicated that the acs systems calibrator f may not be meeting the reconstituted stability claim of 10 days. a shift high in qc values may be observed depending on the recon.